Trial · NCT02474355
Real World Treatment Study of AZD9291 for Advanced/Metastatic EGFR T790M Mutation NSCLC
NCT02474355, Phase 3, Completed, AstraZeneca; results first posted 2021-10-25
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Real World Treatment Study of AZD9291 for Advanced/Metastatic EGFR T790M Mutation NSCLC. Trials, record NCT02474355. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02474355
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Real World Treatment Study of AZD9291 for Advanced/Metastatic EGFR T790M Mutation NSCLC
- NCT number
- NCT02474355
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 3,017 participants, actual
- Lead sponsor
- AstraZeneca
- Conditions
- Lung Cancer
- Interventions
- T790M+ Testing, Baseline Visit Blood & Urine Testing, Baseline ECG, Visual Slit-Lamp Testing, AZD9291 Dosing
- First posted
- 2015-06-17
- Last updated
- 2021-11-11
- Results first posted
- 2021-10-25
- Limitations and caveats
Participants alive at the time of national reimbursement or site closure were no longer followed for survival and therefore prematurely censored for the OS, PFS, and TTD analysis, leading to less mature data. As the timing of reimbursement and study closure differed between countries, duration of follow-up between sites and countries differed.
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Survival (OS) | From the date of first dose of Osimertinib until the date of death (due to any cause) or last participant contact [up to 43 months] | OS was defined as the time, in months from the date of first dose of Osimertinib until death due to any cause, or at last documented contact with participant status "alive" (in this study any participants alive at study discontinuation, or lost to follow-up was considered being censored at study discontinuation date or at the last known date participant was alive). OS was summarized using a Kaplan-Meier (KM) estimate of the median time to death or censoring together with their 95% confidence intervals. |
| Primary | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months] | Safety assessment of Osimertinib was analyzed by evaluating AEs and SAEs. |
| Secondary | Progression Free Survival | From the date of first dose of Osimertinib until disease progression or death in the absence of progression [up to 43 months] | PFS was defined as the time, in months from first dose of AZD9291/ost/study drug/ study treatment until the date of disease progression or death in the absence of progression. Participants who had not progressed or died at study discontinuation were censored at the time of the latest date of disease assessment. PFS was summarized using KM estimates of the median time to progression or death with their 95% confidence intervals. |
| Secondary | Time to Treatment Discontinuation (TTD) | From the date of first dose of Osimertinib until disease progression or death in the absence of progression [up to 43 months] | TTD or death was assessed as a supportive summary to PFS and defined as the time from the date of the first dose of osimertinib in the study until the date of osimertinib discontinuation or death, regardless of the reason for discontinuation. TTD was summarized using KM estimates of the median times to progression or death or treatment discontinuation. |
| Secondary | Response Rate (RR) | From the date of first dose of Osimertinib until disease progression or death in the absence of progression [up to 43 months] | RR was defined as the number (%) of participants with a best response (by Investigator assessment) of 'responding', regardless of the method of evaluation, and was based on a subset of the full analysis set consisting of subjects with at least one documented response assessment. RR was summarised together with the 95% CI. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Survival (OS) | From the date of first dose of Osimertinib until the date of death (due to any cause) or last participant contact [up to 43 months] | The full analysis set included all participants who received at least one dose of study treatment. No statistical tests were performed, the statistical analyses were descriptive. | Months | MEDIAN |
| PRIMARY | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months] | The full analysis set included all participants who received at least one dose of study treatment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Progression Free Survival | From the date of first dose of Osimertinib until disease progression or death in the absence of progression [up to 43 months] | The full analysis set included all participants who received at least one dose of study treatment. No statistical tests were performed, the statistical analyses were descriptive. | Months | MEDIAN |
| SECONDARY | Time to Treatment Discontinuation (TTD) | From the date of first dose of Osimertinib until disease progression or death in the absence of progression [up to 43 months] | The full analysis set included all participants who received at least one dose of study treatment. No statistical tests were performed, the statistical analyses were descriptive. | Months | MEDIAN |
| SECONDARY | Response Rate (RR) | From the date of first dose of Osimertinib until disease progression or death in the absence of progression [up to 43 months] | The full analysis set included all participants who received at least one dose of study treatment. No statistical tests were performed, the statistical analyses were descriptive. | Percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group14
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Survival (OS) | Osimertinib | 22.8 | 95% Confidence Interval 21.6 to 23.8 | Months | |
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Osimertinib | AE of special interest (AESI) or SAE | 923 | Participants | |
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Osimertinib | AESI or SAE a causally related to Osimertinib | 338 | Participants | |
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Osimertinib | AE leading to dose modification | 414 | Participants | |
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Osimertinib | AE leading to discontinuation | 191 | Participants | |
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Osimertinib | AESI | 113 | Participants | |
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Osimertinib | AESI causally related to Osimertinib | 89 | Participants | |
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Osimertinib | SAE | 657 | Participants | |
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Osimertinib | SAE causally related to Osimertinib | 95 | Participants | |
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Osimertinib | AE leading to death | 152 | Participants |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Osimertinib | 3,014 | |
| Overall Study | COMPLETED | Osimertinib | 1,386 | |
| Overall Study | NOT COMPLETED | Osimertinib | 1,628 |
Source ClinicalTrials.gov
Adverse events484
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Thrombocytopenia | Blood and lymphatic system disorders | Osimertinib | 20 | 3,014 | |
| other | Neutropenia | Blood and lymphatic system disorders | Osimertinib | 16 | 3,014 | |
| other | Myelosuppression | Blood and lymphatic system disorders | Osimertinib | 6 | 3,014 | |
| other | Anaemia | Blood and lymphatic system disorders | Osimertinib | 5 | 3,014 | |
| other | Leukopenia | Blood and lymphatic system disorders | Osimertinib | 3 | 3,014 | |
| other | Pancytopenia | Blood and lymphatic system disorders | Osimertinib | 1 | 3,014 | |
| other | Sinus bradycardia | Cardiac disorders | Osimertinib | 2 | 3,014 | |
| other | Ventricular extrasystoles | Cardiac disorders | Osimertinib | 2 | 3,014 | |
| other | Atrial fibrillation | Cardiac disorders | Osimertinib | 1 | 3,014 | |
| other | Atrioventricular block first degree | Cardiac disorders | Osimertinib | 1 | 3,014 |
1 to 10 of 484Source ClinicalTrials.gov
See all 484 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Osimertinib | 1,361 | 3,014 |
| Total, other adverse events | Osimertinib | 380 | 3,014 |
| Total, serious adverse events | Osimertinib | 657 | 3,014 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02474355
GET https://conductscience.org/api/trials/v1/NCT02474355/events?page=2